MERCK SHARP DOHME — Keytruda FDA Review (NDA/BLA 125514, 2020)
Merck & Co., Inc. · 2020 · FDA Review (Drugs@FDA) · company profile →
Report summary
The FDA approved Merck's KEYTRUDA (pembrolizumab) on June 24, 2020, for a 400 mg every 6 weeks dosage in adult patients with recurrent or metastatic cutaneous squamous cell carcinoma (cSCC) not curable by surgery or radiation, under accelerated approval. This approval was supported by pharmacokinetic data and clinical data from KEYNOTE-555, showing a 39% ORR. The report details KEYTRUDA's extensive approved indications across various cancers, including melanoma, NSCLC, and HCC, with specific dosing regimens for monotherapy and combination therapies. Efficacy results from numerous KEYNOTE trials demonstrate benefits in overall survival, progression-free survival, and objective response rates. The safety profile, consistent across indications, highlights immune-mediated adverse reactions (pneumonitis, colitis, endocrinopathies), infusion-related reactions, and complications with allogeneic HSCT. While some fatal adverse events were observed in trials like KEYNOTE-629, no new safety signals were identified, supporting its overall safety profile.
Key findings — cited to the page
| Pneumonitis Grade 5 incidence in HNSCC (combination with platinum and FU) | 0.4 % | KEYTRUDA · p.19 |
| Colitis Grade 2 incidence | 0.4 % | KEYTRUDA · p.19 |
| Pneumonitis Grade 3 incidence in HNSCC (single agent) | 1.3 % | KEYTRUDA · p.19 |
| Pneumonitis Grade 3 incidence in HNSCC (combination with platinum and FU) | 1.1 % | KEYTRUDA · p.19 |
| Pneumonitis Grade 5 incidence | 0.1 % | KEYTRUDA · p.18 |
| Pneumonitis Grade 4 incidence | 0.3 % | KEYTRUDA · p.18 |
| Pneumonitis Grade 2 incidence | 1.3 % | KEYTRUDA · p.18 |
| Pneumonitis Grades 3-4 incidence in NSCLC (single agent, first-line) | 3.2 % | KEYTRUDA · p.19 |
| Pneumonitis Grade 1 incidence | 0.8 % | KEYTRUDA · p.18 |
| Pneumonitis Grade 5 incidence in HNSCC (single agent) | 0.3 % | KEYTRUDA · p.19 |
| Pneumonitis Grade 3 incidence | 0.9 % | KEYTRUDA · p.18 |
| Colitis Grade 3 incidence | 1.1 % | KEYTRUDA · p.19 |
Source: Merck & Co., Inc. ↗ · License: US Government public domain. Summary and findings are extracted from the published document; every figure cites its page. Informational only — not investment advice. Explore the Oncology library →